NCT05903547

A Skin Glue Versus Subcuticular Suture for Cesarean Closure Study

Glue Versus Subcuticular Suture for Cesarean Closure: a Randomized Control Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to compare cesarean incision outcomes between patients with incision closed with the Dermabond Prineo system compared to standard subcuticular suture.

Detailed description

The purpose of this study is to assess patient satisfaction with their incision after undergoing cesarean delivery. Patient satisfaction with their cesarean scar at 4-6 weeks after their surgery will be compared amongst women receiving skin closure with the Dermabond Prineo skin adhesive system versus standard subcuticular suture. Dermabond Prineo has been shown to have improved cosmesis outcomes in non-obstetric populations but has not yet been studied for women receiving cesarean section. In addition to scar appearance, outcomes such as wound infection, postoperative pain, and operative time will be assessed.

Conditions

• Cesarean Section
• Complication
• Wound

Interventions

Type	Name	Description
DEVICE	Dermabond Prineo	For subjects in the Dermabond Prineo group, the Dermabond Prineo system will be applied to the skin for skin closure under manufacturer's guidelines.
OTHER	Suture	For subjects in the Suture group, the skin will be closed with the standard subcuticular suture method.

Timeline

• Start date: 2023-08-23
• Primary completion: 2024-12-06
• Completion: 2025-02-05
• First posted: 2023-06-15
• Last updated: 2026-04-07
• Results posted: 2026-01-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study